
The Portuguese Health Regulatory Authority (ERS) must carry out inspections and audits on a regular basis, in accordance with previously approved inspection plans, and whenever circumstances indicate potential disruptions in the respective sector of activity.
Staff authorised by ERS to carry out an survey, inspection and inspection or audits are equated to law enforcement officers and may:
a) Access all premisses, lands and vehicles belonging to companies and other entities subject to ERS’s activities, including those collaborating with them;
b) Inspect the books, and other records relating to companies and other entities subject to ERS’s activities including those collaborating with them, regardless of the medium in which they are held, with the exception of access to patients' clinical records.
c) Obtain, by any means, copies or extracts of the documents under review.
d) Request from any legal representative, employee or collaborator of the company or other entities subject to ERS’s activities as well those collaborating with them, clarifications regarding facts or documents related to the subject matter and purpose of surveillance, inspection or audit and record their responses.
e) Identify, for the purposes of any subsequent proceedings, the entities or individuals who infringe the laws and regulations subject to ERS surveillance.
f) Request the assistance of police or administrative authorities when deemed necessary for the proper performance of their duties.

